HECTOROL Capsule / Solution for injection Ref.[10031] Active ingredients: Doxercalciferol

2.1 Prior to Initiation of HECTOROL Capsules or Injection

• Ensure serum calcium is not above the upper limit of normal before initiating treatment with HECTOROL capsules or injection [see Warnings and Precautions (5.1)].

2.2 Dosage Recommendations for HECTOROL Capsules in Patients with Stage 3 or 4 CKD

• Initiate HECTOROL capsules at a dose of 1 mcg orally once daily.
• Target the maintenance dose of HECTOROL to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits.
• Monitor serum calcium, phosphorus, and intact PTH levels at least every two weeks for 3 months after initiation of therapy or dose adjustment, then monthly for 3 months, and every 3 months thereafter.
• Titrate the dose of HECTOROL capsules based on intact PTH. The dose may be increased at 2-week intervals by 0.5 mcg to achieve the desired therapeutic range of intact PTH. The maximum recommended dose of HECTOROL capsules is 3.5 mcg administered once daily. Prior to raising the dose, ensure serum calcium is within normal limits.
• Suspend or decrease the dose if intact PTH is persistently and abnormally low to reduce the risk of adynamic bone disease [see Warnings and Precautions (5.4)] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions (5.1)]. If suspended, the drug should be restarted after one week at a dose that is at least 0.5 mcg lower.

2.3 Dosage Recommendations for HECTOROL Capsules in Patients with CKD on Dialysis

• Initiate HECTOROL capsules at a dose of 10 mcg orally administered three times weekly at dialysis (no more frequently than every other day).
• Target the maintenance dose of HECTOROL to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits.
• Monitor serum calcium, phosphorus, and intact PTH levels frequently (e.g., weekly) after initiation of therapy or dose adjustment.
• Titrate the dose of HECTOROL capsules based on intact PTH. The dose may be increased at 8-week intervals by 2.5 mcg to achieve the desired therapeutic range of intact PTH. The maximum recommended dose of HECTOROL is 20 mcg administered three times weekly at dialysis for a total dose of 60 mcg weekly. Prior to raising the dose, ensure serum calcium is within normal limits.
• Suspend or decrease the dose if intact PTH is persistently and abnormally low to reduce the risk of adynamic bone disease [see Warnings and Precautions (5.4)] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions (5.1)]. If suspended, the drug should be restarted one week later at a dose that is at least 2.5 mcg lower.

2.4 Important Administration Instructions for HECTOROL Injection

• Administer HECTOROL injection intravenously as a bolus dose at the end of dialysis.
• Inspect HECTOROL injection visually prior to administration; the solution should appear clear and colorless. Do not use if the solution is not clear or particles are present.
• After initial vial use:
  • discard unused portion of the single-dose vial;
  • store opened multiple-dose vial for up to 3 days at 2°C to 8°C (36°F to 46°F). Discard unused portion of multiple-dose vial after 3 days [see How Supplied/Storage and Handling (16)].

2.5 Dosage Recommendations for HECTOROL Injection in Patients with CKD on Dialysis

• Initiate HECTOROL injection at a dose of 4 mcg given by bolus intravenous administration three times weekly at the end of dialysis (no more frequently than every other day).
• Target the maintenance dose of HECTOROL to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits.
• Monitor serum calcium, phosphorus, and intact PTH levels weekly after initiation of therapy or dose adjustment.
• Titrate the dose of HECTOROL injection based on intact PTH. The dose may be increased at 8-week intervals by 1 mcg to 2 mcg if intact PTH is not lowered by 50% and fails to reach the target range. The maximum dose is 18 mcg weekly. Prior to raising the dose, ensure serum calcium is within normal limits.
• Suspend or decrease the dose if intact PTH is persistently and abnormally low to reduce the risk of adynamic bone disease [see Warnings and Precautions (5.4)] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions (5.1)]. If suspended, the drug should be restarted one week later at a dose that is at least 1 mcg lower.

2.6 Drug Interactions that May Require Dosage Adjustments of HECTOROL

• Increased monitoring of serum calcium and dose adjustment of HECTOROL may be necessary when given concomitantly with drugs that may increase the risk of hypercalcemia [see Drug Interactions (7)].
• Increased monitoring of both serum calcium and intact PTH as well as dose adjustment of HECTOROL may be necessary when given concomitantly with cytochrome P450 inhibitors or enzyme inducers [see Drug Interactions (7)].

Overdosage of HECTOROL may lead to hypercalcemia, hypercalciuria, and hyperphosphatemia [see Warnings and Precautions (5.1)]. The treatment of acute overdosage should consist of supportive measures and discontinuation of HECTOROL administration. Serum calcium levels should be measured until normal.

Based on similarities between doxercalciferol and its active metabolite, 1α,25-(OH)₂D₂, it is expected that doxercalciferol is not removed from the blood by dialysis.

* Protect from light. Store unopened vial in original carton.